PDA Southeast Chapter

Chapter Officers

• 
  Casey Poirier

  President

  STERIS Corporation

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  Casey Bailey Poirier is a North Carolina native and an Account Manager with STERIS Corporation Life Sciences Division. Her current responsibilities include providing contamination control solutions related to disinfection, process cleaning, and sterility assurance for the biotech, pharmaceutical, and medical device industries. Casey leverages over 12 years of experience in QC Chemistry, QC Microbiology, and Validation roles. Prior to joining STERIS, she served as a Lead Validation Engineer for Stallergenes Greer where she oversaw the site process simulation program, led projects to continuously improve validation and quality system programs, and enhance equipment performance capabilities. During her tenure as a validation professional, she became well versed with PDA Technical Reports as a guideline for compliance during these initiatives. She earned a Bachelor of Science in Biology at Wingate University and Master of Business Administration in Project Management. In addition, she holds Lean Six Sigma Green Belt Certification from University of North Carolina at Charlotte.
• 
  Kim Sobien

  President-Elect

  ValSource

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  Kim has a BS in Microbiology from the University of Wisconsin–La Crosse and a Master of Business (MBA) degree with an emphasis in Global Management from the University of Phoenix. She is an active member of the Parenteral Drug Association (PDA) and the PDA Southeast Chapter, Co-Lead for the PDA EM/Microbiology Interest group, and a past co-chair and committee member for the PDA Pharmaceutical Microbiology Conference.  She also participates on several ASTM E55.06 “Microbial and Sterility Assurance” subcommittees.
• 
  Amanda Bishop McFarland

  Treasurer

  Valsource, LLC

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  Amanda is a Senior Consultant for ValSource and in this role assists companies with the design and implementation of CGMPs, Microbiology, and Quality Risk Management programs. She specializes in the creation and implementation of risk management programs, contamination control strategies, developing risk-based strategies and risk facilitation. Prior to joining ValSource, Amanda worked to integrate risk management program within a multi-national company by developing the procedures required and training the organization in the execution of consistent risk management tools. Ms. McFarland currently serves as the PDA QRM interest group co-lead, PDA Membership Advisory Committee (MAC) co-chair, PDA QRM/Aseptic processing co-chair and a faculty member of the Quality Risk Management Certificate Training Series at PDA training institute.
• 
  Michelle Dennis

  Secretary

  MilliporeSigma

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  Michelle Dennis joined MilliporeSigma in May of 2015, and has been the QC Microbiology specialist in NC for the last 5 years. She is responsible for supporting pharmaceutical microbiology laboratories within North Carolina on their methods for sterility, bioburden testing, environmental monitoring and pyrogen testing. She works closely with QC Microbiology lab managers and their teams in NC and enjoys identifying areas where she can simultaneously enhance efficiency and compliance in the lab and establish partnerships between the client and vendor. Michelle received her Bachelors of Science in Microbiology from the University of Maryland, College Park in 2006. Michelle has found the PDA to be very helpful in her career, and she enjoys connecting microbiologists that are not currently aware of the PDA to its’ resources and community. She shares PDA news and events with those within the industry, and sees huge opportunity for engagement among pharmaceutical microbiologists in NC. Continued education, shared best practices, mentorship, and diversity within our field are important principles that Michelle can help contribute to as a Board Member-at-Large.
• 
  Austin Caudle

  Past-President

  Redica Systems

  austin.caudle@redica.com

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  Austin Caudle, MSc, MRQA is a Senior Enterprise Sales Executive with Redica Systems, a software company that provides regulatory and compliance data intelligence to Quality & regulatory experts around the world. He has over 20 years of experience as a business leader accelerating growth, profitability, and value in the highly competitive biotech, pharma, and medical device markets. His industry experience spans the many facilities and processes necessary to bring a drug/biologic/device to market – from the laboratory and R&D through manufacturing. Prior to joining Redica Systems, Austin served as a SME at Kelly Science & Clinical and held positions at Fortune 500 companies, IQVIA and ThermoFisher Scientific, and leadership roles at NSF Health Sciences and Charles River.

  Mr. Caudle studied Nutrition and Food Science at Auburn University in Auburn, Alabama USA. He holds a BSc in Nutrition and Food Science and an MSc in Food Science and is published in several scientific journals for academic research. Austin has served on the Southeast Chapter Board of Directors, participated in multiple program planning committees as a contributor/moderator, an author/contributor to the PDA Letter, and was recognized as a leader in the Volunteer Spotlight with the Parenteral Drug Association (PDA), an invited speaker on AI and Data Science in Next Generation Clinical Development at the Precision Medicine World Conference (PMWC), and twice served as Co-Chair for the International Pharmaceutical Excipients Council (IPEC) World Conference Planning Committee. He is a member of PDA, ISPE, AAPS, RAPS, and RQA professional associations.